Cytoki Pharma Announces Positive Phase 1 Data Showing Potential of CK-0045 to Improve Cardiometabolic Risk Factors
Cytoki Pharma Announces Positive Phase 1 Data Showing Potential of CK-0045 to Improve Cardiometabolic Risk Factors
CK-0045 induced exposure-dependent reductions in body weight and improvement of key metabolic parameters in participants with obesity
Ck-0045誘導的曝光依賴性減輕了肥胖參與者的體重,並且改善了關鍵代謝參數。
Data support advancement of CK-0045 into Phase 2 proof-of-concept studies in individuals with type 2 diabetes and/or obesity
數據支持Ck-0045進入II期概念證明研究,以治療二型糖尿病和/或肥胖個體。
COPENHAGEN, Denmark, July 23, 2024 /PRNewswire/ -- Cytoki Pharma, ApS (Cytoki), a clinical-stage biotechnology company pioneering a new class of medicines that harness IL-22 biology to drive improved outcomes for metabolic disease, today announced positive data from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of CK-0045, its lead lipidated IL-22 candidate, in healthy participants and otherwise healthy participants with obesity. The data signal the effect of CK-0045 across several key metabolic parameters including body weight, cholesterol, blood glucose levels, and insulin sensitivity.
2024年7月23日,丹麥哥本哈根 / PRNewswire / - 臨床階段的生物技術公司Cytoki Pharma,ApS(Cytoki)是首創一種新型藥物的開創者,利用IL-22生物學來推動代謝性疾病的改善,今天宣佈了Ck-0045的一項1期研究的積極數據,該研究評估了其領先的脂質化IL-22候選藥物在健康參與者和否則健康肥胖參與者中的安全性,耐受性和藥代動力學。數據表明Ck-0045在包括體重、膽固醇、血糖水平和胰島素敏感性等多個關鍵代謝參數上的作用。
"As the obesity treatment landscape continues to evolve, there remains a need for approaches that drive lasting disease modification through healthy weight loss and broader, deeper weight loss-independent metabolic effects," said Rasmus Jorgensen, Ph.D., Founder and CEO of Cytoki Pharma. "We believe CK-0045 offers a differentiated opportunity to address obesity and type 2 diabetes, either as monotherapy or in combination with other clinical approaches and are encouraged by these first data supporting CK-0045's unique mechanism of action."
"隨着肥胖治療格局的不斷髮展,需要通過健康減重和更廣泛,更深入的減重獨立的代謝效應來推動持久的疾病改善,"Cytoki Pharma博士Rasmus Jorgensen說。 "我們相信Ck-0045提供了一種不同尋常的機會來應對肥胖和二型糖尿病,無論是作爲單一療法還是與其他臨床方法的組合,對這些第一批數據支持Ck-0045的獨特機制的行動感到鼓舞。"
IL-22 is a non-immunomodulatory cytokine that selectively targets epithelial tissues such as the gut and liver. Previously reported preclinical data demonstrate the potential of lipidated IL-22 to reduce body weight and improve glucose homeostasis in mice through a novel mode-of-action.
IL-22是一種非免疫調節因子,選擇性地靶向腸道和肝臟等上皮組織。此前報道的臨床前數據表明,脂質化IL-22在小鼠中通過新穎作用方式,降低體重並改善葡萄糖代謝。
Results from the Phase 1 study signal successful translation of the preclinical findings to humans, with confirmed target engagement based on liver and gut-derived biomarkers. Pharmacokinetic data confirm feasibility of once weekly subcutaneous dosing. CK-0045 induced exposure-dependent reductions in body mass that were complemented by beneficial reductions in low-density lipoprotein cholesterol, blood insulin concentration, and insulin resistance—particularly in participants with reduced insulin sensitivity.
來自1期研究的結果表明,將臨床前發現成功應用於人類,基於肝臟和腸道生物標誌物確認了Ck-0045的靶向作用。藥代動力學數據證實了一週一次的皮下劑量可行性。Ck-0045誘導了暴露依賴性的體重減輕,補充了低密度脂蛋白膽固醇,血胰島素濃度和胰島素抵抗等有益減少,特別是在減少胰島素敏感性的參與者中。
CK-0045 was safe and tolerated across the multiple ascending dose portion of the study, with all but one participant having completed dosing. The most commonly occurring side effects were mild skin reactions and a notable absence of substantial gastrointestinal effects was observed.
在多劑量遞增部分的研究中,Ck-0045是安全且無副作用的,除一名參與者未完成劑量外。最常見的副作用是輕微的皮膚反應,並觀察到沒有實質性的胃腸道副作用。
The available clinical data support advancement of CK-0045 into Phase 2 proof-of-concept studies in individuals with obesity and type 2 diabetes to further assess the clinical relevance of observed effects. Initiation of the Phase 2 is anticipated in the second half of 2024.
可用的臨床數據支持Ck-0045進入面向肥胖和二型糖尿病個體的II期概念證明研究,以進一步評估觀察到的效果的臨床相關性。第二階段的啓動預計在2024年下半年進行。
About CK-0045
CK-0045 is a long-acting analogue of interleukin-22 (IL-22), an atypical, non-immunomodulatory cytokine that selectively targets epithelial cells. In-licensed from Novo Nordisk A/S, CK-0045 incorporates validated technology to optimize the pharmacologic properties of the endogenous IL-22 protein to create a differentiated, first-in-class therapy with potential to address a broad range of metabolic diseases, including obesity and type 2 diabetes, and conditions characterized by epithelial injury, such as inflammatory bowel disease. CK-0045 has been evaluated in a randomized, double-blind, placebo-controlled Phase 1 study designed to investigate its safety, tolerability, and pharmacokinetics in healthy individuals with and without obesity (NCT05712876). CK-0045 is expected to enter Phase 2 studies in the second half of 2024.
關於Ck-0045:Ck-0045是IL-22(白細胞介素-22)的長效類似物,一種非免疫調節細胞因子,選擇性靶向上皮細胞。從Novo Nordisk A/S獲得許可,Ck-0045採用驗證技術來優化內源性IL-22蛋白的藥理特性,創造出一種具有差異性的,首創的治療方法,有潛力治療廣泛的代謝性疾病,包括肥胖和二型糖尿病以及表皮損傷等情況,如炎症性腸道疾病。Ck-0045已在隨機、雙盲、安慰劑對照的1期研究中得到評估,旨在研究其在健康個體中的安全性,耐受性和藥代動力學,其中包括肥胖和非肥胖個體(NCT05712876)。預計Ck-0045將在2024年下半年進入第2期研究。
關於Cytoki Pharma:Cytoki Pharma是臨床階段的生物技術公司,率先開創一種新型藥物,利用IL-22生物學來推動心血管代謝性疾病的改善。Cytoki的領導項目Ck-0045是一個脂質化的IL-22類似物,已經在1期臨床研究中得到評估,並預計將於2024年下半年進入2期臨床研究。所選的主要化合物來自Novo Nordisk A / S的獨家許可證。該公司還推進了用於代謝性疾病和炎症性腸病治療的更廣泛的預臨床IL-22基礎資產組合。Cytoki成立於2019年,由醫藥行業的資深人員組成,具有在新藥發現和臨床開發方面的廣泛專業知識。欲了解更多詳情,請訪問或關注我們的LinkedIn。
About Cytoki Pharma
Cytoki Pharma is a clinical-stage biotechnology company pioneering a new class of medicines that harness IL-22 biology to drive improved outcomes for cardiometabolic disease. Cytoki's lead program, CK-0045, is a lipidated IL-22 analogue that has been evaluated in a Phase 1 clinical study and is expected to enter Phase 2 clinical studies in the second half of 2024. The lead compound is selected from a full program of therapeutic IL-22 variants based on an exclusive license from Novo Nordisk A/S. The company is also advancing a broader portfolio of preclinical IL-22-based assets for the treatment of metabolic disease and inflammatory bowel disease. Cytoki was founded in 2019 and is led by a team of pharma industry veterans with deep expertise in the discovery and clinical development of novel drugs. Please visit or follow us on LinkedIn for additional details.
關於Cytoki Pharma:Cytoki Pharma是臨床階段的生物技術公司,率先開始開創一種新型藥物,利用IL-22生物學來推動心血管代謝性疾病的改善。Cytoki的領導項目Ck-0045是一個脂質化的IL-22類似物,已經在1期臨床研究中得到評估,並預計將於2024年下半年進入2期臨床研究。所選的主要化合物來自Novo Nordisk A / S的獨家許可證。該公司還推進了用於代謝性疾病和炎症性腸病治療的更廣泛的預臨床IL-22基礎資產組合。Cytoki成立於2019年,由醫藥行業的資深人員組成,具有在新藥發現和臨床開發方面的廣泛專業知識。欲了解更多詳情,請訪問或關注我們的LinkedIn。
Cytoki Pharma是臨床階段的生物技術公司,率先開創一種新型藥物,利用IL-22生物學來推動心血管代謝性疾病的改善。Cytoki的領導項目Ck-0045是一個脂質化的IL-22類似物,已經在1期臨床研究中得到評估,並預計將於2024年下半年進入2期臨床研究。所選的主要化合物來自Novo Nordisk A / S的獨家許可證。該公司還推進了用於代謝性疾病和炎症性腸病治療的更廣泛的預臨床IL-22基礎資產組合。Cytoki成立於2019年,由醫藥行業的資深人員組成,具有在新藥發現和臨床開發方面的廣泛專業知識。請訪問或關注我們的LinkedIn以獲取更多詳情。
SOURCE Cytoki Pharma
消息來源:Cytoki Pharma